Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Status: Recruiting
Location: See all (64) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Age ≥ 50 years
• Have the capacity to consent on his/her own behalf
• Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site
• Willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days)
• Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20/320 or better (Snellen))
• Previously untreated, active MNV lesion (i.e., any intraretinal or subretinal fluid within the center 3 mm diameter circle on OCT) secondary to age-related macular degeneration
• ≥ 1 intermediate drusen (≥ 63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye
Locations
United States
California
Kent W. Small, MD, AMC
RECRUITING
Glendale
Loma Linda University
RECRUITING
Loma Linda
East Bay Retina Consultants, Inc.
RECRUITING
Oakland
Kaiser Permanente - Oakland
RECRUITING
Oakland
Southern California Desert Retina Consultants, Inc.
RECRUITING
Palm Desert
UC Davis Health Eye Center
RECRUITING
Sacramento
Macula Retina Vitreous Institute
RECRUITING
Torrance
Bay Area Retina Associates A Medical Group
RECRUITING
Walnut Creek
Connecticut
Retina Consultants
RECRUITING
Manchester
Florida
National Ophthalmic Research Institute
RECRUITING
Fort Myers
National Ophthalmic Research Institute
RECRUITING
Fort Myers
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
RECRUITING
Jacksonville
University of Florida- Jacksonville
RECRUITING
Jacksonville
Argus Research Center, Inc
RECRUITING
Naples
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
RECRUITING
Pinellas Park
Retina Associates of Sarasota
RECRUITING
Sarasota
Sarasota Retina Institute
RECRUITING
Sarasota
Retina Associates of Florida, LLC
RECRUITING
Tampa
Georgia
Southeast Retina Center, P.C.
RECRUITING
Augusta
Thomas Eye Group
RECRUITING
Sandy Springs
Iowa
Wolfe Clinic, P.C.- West Des Moines
RECRUITING
West Des Moines
Illinois
Northwestern Memorial Group
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
UIC - Dept of Ophthalmology & Visual Sciences
RECRUITING
Chicago
Indiana
Midwest Eye Institute
RECRUITING
Indianapolis
The Trustees of Indiana University
RECRUITING
Indianapolis
Kansas
Mid-America Retina Consultants, P.A.
RECRUITING
Overland Park
Kentucky
University of Kentucky Advanced Eye Care
RECRUITING
Lexington
Massachusetts
Valley Eye Physicians and Surgeons
RECRUITING
Ayer
Joslin Diabetes Center
RECRUITING
Boston
Maryland
Elman Retina Group, BA
RECRUITING
Baltimore
Johns Hopkins University
RECRUITING
Baltimore
Michigan
Henry Ford Health System
RECRUITING
Detroit
Retina Associates of Michigan
RECRUITING
Grand Blanc
Associated Retinal Consultants, P.C.
RECRUITING
Royal Oak
Associated Retinal Consultants
RECRUITING
Traverse City
Missouri
The Retina Institute
RECRUITING
St Louis
New Jersey
Associated Retinal Surgeons d/b/a Mid Atlantic Retina
RECRUITING
Cherry Hill
New York
Macula Care
RECRUITING
New York
New York University Langone Health
RECRUITING
New York
Vitreous Retina Macula Consultants of NY - VRMNY
RECRUITING
New York
Retina Associates of Western NY, P.C.
RECRUITING
Rochester
Ohio
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
RECRUITING
Cleveland
Oklahoma
Retina Vitreous Center
RECRUITING
Edmond
Oregon
Verum Research LLC
RECRUITING
Eugene
Oregon Health & Science University
RECRUITING
Portland
Cascade Medical Research Institute, LLC
RECRUITING
Springfield
Pennsylvania
Retina Vitreous Consultants
RECRUITING
Monroeville
The Trustees of the University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Hilton Head Retina Institute
RECRUITING
Hilton Head Island
South Dakota
Ophthalmology Ltd.
RECRUITING
Sioux Falls
Tennessee
Southeastern Retina Associates, P.C.
RECRUITING
Knoxville
Texas
Austin Research Center for Retina
RECRUITING
Austin
Retina Consultants of Texas, PA
RECRUITING
Bellaire
UT Southwestern Medical Center
RECRUITING
Dallas
Southwest Retina Consultants
RECRUITING
El Paso
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
RECRUITING
Houston
Texas Retina Associates
RECRUITING
Lubbock
Retina Associates of South Texas
RECRUITING
San Antonio
Retinal Consultants of Texas
RECRUITING
San Antonio
Wisconsin
The Board of Regents of the University of Wisconsin System
RECRUITING
Madison
Eye Clinic of Wisconsin
RECRUITING
Wausau
Other Locations
Canada
Chow Berger Koushan Medicine Professional Corporation o/a Toronto Retina Institute
RECRUITING
North York
University Health Network
RECRUITING
Toronto
Time Frame
Start Date: 2023-11-09
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 600
Treatments
Experimental: Treat and Extend
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Experimental: Home optical coherence tomography-Guided Treatment
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Related Therapeutic Areas
Sponsors
Collaborators: Juvenile Diabetes Research Foundation, National Institutes of Health (NIH), National Eye Institute (NEI)
Leads: Jaeb Center for Health Research